The data obtained from the transplant study will give the...

The data obtained from the transplant study will give the necessary evidence that afamelanotide is protective against skin cancer. This background study should help getting afamelanotide to the general high risk, type I population.

Modern medicine is evolving and it is common to see doctors trying drug for treatment from not already approved indications. "Physicians may safely prescribe any drug off-label provided he or she practices a standard of care based on sound evidence". Taken from the article below.

Off-label prescription of afamelanotide is bound to happen (think American doctors). This will force the regulators to demand proper trials in the general population but they will not necessarily be able to stop administration to unapproved indications.

Just my opinions.

Off-label Use of Prescription Medication: A Literature Review
VOLUME: 22 PUBLICATION DATE: Apr 01 2010
author:
Robert G. Smith, DPM, MSc, RPh, CPed
"The practice of off-label prescribing of drugs and medical devices plays an important therapeutic role in many disease states, including psychiatric disorders, human immunodeficiency virus (HIV), and diseases in children and other patient populations that are underserved by approved medicines. When medications and devices are used off-label for medical treatment, their primary purpose is to benefit the individual patient. Within the scope of medical practice, the clinicians primary purpose and intention when using a product off-label is to enhance the wellbeing of the patient with an expectation of success. It is clear that rapid developments in medical science often outpace the speed with which regulatory authorities like the FDA can move to implement new legislation.5 Physicians may safely prescribe any drug off-label provided he or she practices a standard of care based on sound evidence".